Catalog Number

004-05

Brand Name

HUDSON RCI

Version/Model Number

IPN040284

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141214,K141214

Product Code

CAF

Product Code Name

NEBULIZER (DIRECT PATIENT INTERFACE)

Public Device Record Key

3a85c36c-cc30-4bb7-b622-aabd71fa4aee

Public Version Date

November 15, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

24026704597059

Quantity per Package

20

Contains DI Package

04026704597055

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case